Division of Neonatology, Department of Pediatrics, Evanston Hospital, NorthShore University HealthSystem, Evanston, IL.
Pritzker School of Medicine, University of Chicago, Chicago, IL.
Pediatr Crit Care Med. 2019 Jun;20(6):e251-e257. doi: 10.1097/PCC.0000000000001921.
Primary objectives were to discover current practices of informed consent for bedside procedures in the PICU and neonatal ICU and how trainees learn to obtain consent. We also attempted to gauge if program directors felt that one method of consent was subjectively superior to another in the way it fulfilled established ethical criteria for informed consent.
An online anonymous survey. Participants were asked about how and by whom informed consent is currently obtained, training practices for fellows, and attitudes about how different consent methods fulfill ethical criteria.
All U.S. fellowship programs for neonatology (n = 98) and pediatric critical care (n = 66) in the fall of 2017.
Neonatal and pediatric critical care fellowship program directors.
None.
The overall response rate was 50% (82 of 164). The most common method for obtaining consent in both ICU types was via a written, separate (procedure-specific) consent (63% neonatal ICUs, 83% PICUs); least common was verbal consent (8% neonatal ICUs and 6% PICUs). Fellows were reported as obtaining consent most often (91%), followed by mid-level practitioners (71%) and residents (66%). Residents were one-fifth as likely to obtain consent in the PICU as compared with the neonatal ICU. Sixty-three percent of fellowship directors rated their programs as "strong" or "very strong" in preparing trainees to obtain informed consent. Twenty-eight percent of fellowship directors reported no formal training on how to obtain informed consent.
Most respondents' ICUs use separate procedure-specific written consents for common bedside procedures, although considerable variability exists. Trainees reportedly most often obtain informed consent for procedures. Although most fellowship directors report their program as strong in preparing trainees to obtain consent, this study reveals areas warranting improvement.
主要目的是发现儿科重症监护病房（PICU）和新生儿重症监护病房（NICU）中床边程序知情同意的当前实践，以及受训者如何学习获得同意。我们还试图评估项目主管是否认为一种同意方法在满足知情同意的既定伦理标准方面主观上优于另一种方法。
在线匿名调查。参与者被问及当前如何以及由谁获得知情同意，如何对研究员进行培训，以及对不同同意方法如何满足伦理标准的态度。
2017 年秋季，全美所有新生儿科（n=98）和儿科重症监护（n=66） fellowship项目。
新生儿和儿科重症监护 fellowship项目主任。
无。
总体回复率为 50%（164 名中的 82 名）。两种 ICU 类型中最常见的获取同意的方法是通过书面的、单独的（特定程序）同意（63%的新生儿 ICU，83%的 PICU）；最不常见的是口头同意（8%的新生儿 ICU 和 6%的 PICU）。据报道，研究员最常获得同意（91%），其次是中级从业者（71%）和住院医师（66%）。与新生儿 ICU 相比，住院医师在 PICU 获得同意的可能性低五分之一。63%的 fellowship 主任对其项目在培训受训者获取知情同意方面的评价为“强”或“非常强”。28%的 fellowship 主任报告称，他们没有接受过如何获取知情同意的正式培训。
大多数受访者的 ICU 使用单独的特定程序书面同意书来进行常见的床边程序，尽管存在相当大的差异。据报道，受训者通常最常获得程序的知情同意。尽管大多数 fellowship 主任报告称他们的项目在培训受训者获取同意方面很强，但这项研究揭示了需要改进的领域。
